In this study, patients with uncomplicated urinary infection are investigated. It is investigated if treatment of only symptoms of the uncomplicated urinary infection is as effective as treatment with antibiotics with respect to the outcome of the urinary infection. If this is the case, the use of antibiotics in the treatment of uncomplicated urinary infections might be reduced. Secondary aim of the study is the safety evaluation of both treatment strategies with respect to SAEs during treatment. Additionally, relapse frequency after 28 days is evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
494
400 mg oral once a day from day 0 for 3 days
8 g granulate with 3 g Fosfomycin-Trometamol oral once at day 0, placebo to Ibuprofen once a day oral from day 0 for 3 days
Univercity Medical Center Goettingen
Göttingen, Germany
MHH Hannover
Hanover, Germany
number of additional treatments with antibiotics combined with number of symptoms
The study outcome is considered as positive, if the interventional group where only symptoms were treated has less additional treatments with antibiotics as the interventional group, where antibiotics are given from day 0 on. Additionally, the interventional group where only symptoms were treated has to be non inferior with respect to number of symptoms.
Time frame: day 0-28
number of defined daily doses of antibiotics
Time frame: day 0-28
number of SAEs
Time frame: day 0-28
number of relapses
Time frame: day 0-28
number of patients without symptoms
Time frame: day 4 and day 7
symptom load (AUC)
Time frame: day 0-4
symptom load
Time frame: day 0-7
symptoms load with regard to specific symptoms
Time frame: day 0-7
activity impairment assessment
Time frame: day 0-7
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